AirSeal vs DV5 for Postoperative Pain

("CAT5-GS" Trial)

Overseen By Cynthia L Harris, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SurgiQuest, Inc.

Must not be taking: Pain killers, Steroids

Disqualifiers: Hypertension, Diabetes, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether the AirSeal or DV5 device better reduces shoulder, neck, and chest pain after robotic gastric sleeve surgery. Both devices create space in the body during surgery, but researchers seek to identify if one provides more comfort for patients afterward. Individuals planning to undergo non-emergency sleeve gastrectomy, without major health issues like uncontrolled high blood pressure or diabetes, might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance post-surgical comfort for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on regular painkillers, you may not be eligible to participate.

What prior data suggests that these insufflation devices are safe for gastric sleeve procedures?

Research has shown that the AirSeal Insufflation system is generally well-tolerated by patients. It maintains a stable space during surgery and reduces smoke in the operating room, which can smooth the surgical process and potentially lower the risk of complications. Some studies have found that patients may experience less pain after surgery with AirSeal compared to traditional methods.

The DV5 Insufflation system is used with the da Vinci 5 robotic platform, which the FDA has approved for surgeries. This approval indicates it has passed safety checks for other procedures, although limited safety data may exist for this specific study. Both systems aim to improve surgical outcomes, and while more research is needed for direct comparison, both have shown promise in their roles. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AirSeal and DV5 insufflation systems because they may offer a new way to manage postoperative pain after robotic laparoscopic sleeve gastrectomy. Unlike standard care options that typically focus on medication for pain relief, these systems are used during surgery to control the pressure and flow of the gas in the abdomen. The AirSeal system, in particular, is known for maintaining stable pressure and providing continuous smoke evacuation, which might reduce irritation and pain after the procedure. By potentially minimizing postoperative discomfort, these systems could enhance recovery and improve patient outcomes.

What evidence suggests that these insufflation systems are effective for reducing postoperative pain in gastric sleeve procedures?

This trial will compare the AirSeal Insufflation System with the DV5 Insufflation System for postoperative pain management. Research has shown that the AirSeal Insufflation System can be beneficial during surgery. Studies have found it may lead to fewer complications and less pain after surgery compared to traditional methods. One study showed that surgeries using AirSeal took less time—110 minutes instead of 121 minutes with other systems—potentially leading to quicker recovery and less pain afterward.

In contrast, the DV5 Insufflation System, which participants in this trial may receive, is used with the da Vinci robotic surgery platform. While it helps achieve good surgical results, limited information exists on its impact on postoperative pain. More research is needed to determine if it can provide the same or better benefits as AirSeal. ^{1 2 3 4 6}

Who Is on the Research Team?

Anthony Gonzalez, MD FACS

Principal Investigator

Baptist Health South Miami Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 22-65, classified as ASA Class I-III, who are scheduled for non-emergent sleeve gastrectomy surgery. Participants must understand the procedure and follow post-surgery recommendations without significant psychopathology. They should not plan any weight-affecting elective procedures during the trial.

Inclusion Criteria

I am scheduled for a non-emergency sleeve gastrectomy.

I can sign or have someone legally authorized to sign for me.

I am between 22 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic laparoscopic sleeve gastrectomy using either the AirSeal or DV5 insufflation system

1 day

1 visit (in-person)

Perioperative Monitoring

Participants are monitored for pain and recovery outcomes post-surgery

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AirSeal Insufflation system
• DV5 Insufflation system

Trial Overview

The CAT5-GS study compares two insufflation systems used in robotic laparoscopic gastric sleeve surgeries: AirSeal and DV5. The focus is on assessing shoulder, neck, and chest pain post-operation to determine which system offers better patient comfort.

How Is the Trial Designed?

Group I: DV5 Insufflator Active Control 1 Intervention

Use of DV5 Insufflator during robotic laparoscopic sleeve gastrectomy.

Group II: AirSeal® Insufflation System (AIS) Active Control 1 Intervention

Use of AirSeal® Insufflation System (AIS) during robotic laparoscopic sleeve gastrectomy.

Who Is Running the Clinical Trial?

SurgiQuest, Inc.

Lead Sponsor

Trials

6

Recruited

670+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11392197/

Perioperative outcomes and safety of valveless insufflation ...

Through comparison with convention insufflation system, we found AirSeal may offer more perioperative advantages, less severe complications, and lower incidence ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03418402

Study Details | NCT03418402 | Post Operative Pain After ...

The objective of this study is to compare the use of Airseal® system with a low pression pneumoperitoneum and our standard insufflation system usually used in ...

3.

conmed.com

conmed.com/en/products/airseal-and-insufflation/airseal-data

AirSeal Clinical Study Appendix

Key Takeaways: The AirSeal group showed: A statistically significant difference in the mean operating time (110 minutes in the AirSeal group vs. 121 minutes in ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S147751312500542X

Safety and efficacy of AirSeal® continuous pressure ...

These features are desirable for their potential decrease in intra- and post-operative complications, post-operative pain, and enhance ...

5.

jpurol.com

jpurol.com/article/S1477-5131(25)00542-X/pdf

Safety and efficacy of AirSeal® continuous pressure ...

These features are desirable for their potential decrease in intra- and post-operative com- plications, post-operative pain, and enhance ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39042265/

a systematic review and meta-analysis

This meta-analysis aimed to compare perioperative outcome measures between the AirSeal system and conventional insufflation system in robot-assisted ...